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A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis (ASSET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02161406
Recruitment Status : Completed
First Posted : June 11, 2014
Results First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborators:
Bristol-Myers Squibb
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Dinesh Khanna, MD, MS, University of Michigan

Tracking Information
First Submitted Date  ICMJE June 3, 2014
First Posted Date  ICMJE June 11, 2014
Results First Submitted Date  ICMJE April 4, 2019
Results First Posted Date  ICMJE June 18, 2019
Last Update Posted Date June 18, 2019
Actual Study Start Date  ICMJE September 2014
Actual Primary Completion Date September 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year [ Time Frame: 52 weeks ]
    Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of abatacept, and using serious AEs
  • Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12 [ Time Frame: Baseline and 52 weeks ]
    The efficacy of treatment on skin fibrosis will be measured by changes from baseline to month 12 in mRSS, a measure of skin thickness. mRSS scores have a range from 0 to 51, with higher score indicating greater severity of SSc (worse outcome).
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2014)
  • Incidence of adverse events (AEs) and Serious AEs (SAEs) [ Time Frame: 52 weeks ]
    Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of abatacept, and using serious AEs
  • Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12 [ Time Frame: Baseline and 52 weeks ]
    The efficacy of treatment on skin fibrosis will be measured by changes from baseline to month 12 in mRSS, a measure of skin thickness.
Change History Complete list of historical versions of study NCT02161406 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease [ Time Frame: Baseline and Week 52 ]
    Patient global assessment for overall disease represents the patient's assessment of the patient's global scleroderma on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome.
  • Change From Baseline to Month 12 in Physician Global Assessment for Overall Disease [ Time Frame: Baseline and Week 52 ]
    This assessment represents the physician's assessment of the patient's current disease activity on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome.
  • Change in % Predicted FVC [ Time Frame: Baseline and 52 weeks ]
    FVC is Forced vital capacity, a measure of lung function. FVC % Predicted is calculated using equations from Hankinson [Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999;159(1):179-87], incorporating age, gender, and race. It is calculated as the (FVC Observed / FVC predicted) * 100, where FVC predicted is calculated relative to a reference population.
  • Change From Baseline to Month 12 in FVC (in ml) [ Time Frame: Baseline and Week 52 ]
    FVC = forced vital capacity, a measure of lung function
  • Change From Baseline to Month 12 in HAQ-DI - Overall [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI overall score ranges from 0 (no disability) to 3 (severe disability). Higher score means worse outcome.
  • Change From Baseline to Month 12 in SHAQ-DI VAS - Overall Disease [ Time Frame: Baseline and Week 52 ]
    Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for disease severity ranges from 0 (no disease) to 150 (very severe). A higher score means a worse outcome.
  • Change From Baseline to Month 12 in SHAQ-DI VAS - Breathing [ Time Frame: Baseline and Week 52 ]
    Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much breathing problems interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.
  • Change From Baseline to Month 12 in SHAQ-DI VAS - Raynaud's [ Time Frame: Baseline and Week 52 ]
    Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much Raynaud's interfered with daily activities ranges from 0 (does not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.
  • Change From Baseline to Month 12 in SHAQ-DI VAS - Burden of Digital Ulcers [ Time Frame: Baseline and Week 52 ]
    Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much finger ulcers interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.
  • Change From Baseline to Month 12 in SHAQ-DI VAS - GI Involvement [ Time Frame: Baseline and Week 52 ]
    Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much intestinal problems interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.
  • Change From Baseline to Month 12 in Swollen Joint Count [ Time Frame: Baseline and 52 weeks ]
    28 joints are assessed for swelling (positive or negative). The number of swollen joint count ranges from 0 to 28. A higher number indicates worse outcome.
  • Change From Baseline to Month 12 in Tender Joint Counts [ Time Frame: Baseline and 52 weeks ]
    28 joints are assessed for tenderness (positive or negative). The number of tender joint counts ranges from 0 to 28. A higher number indicates worse outcome.
  • Change From Baseline to Month 12 in PROMIS-29 - Physical Function [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the physical function domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).
  • Change From Baseline to Month 12 in PROMIS-29 - Anxiety [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the anxiety domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
  • Change From Baseline to Month 12 in PROMIS-29 - Depression [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the depression domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
  • Change From Baseline to Month 12 in PROMIS 29 - Fatigue [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the fatigue domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
  • Change From Baseline to Month 12 in PROMIS-29 - Sleep Disturbance [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the sleep disturbance domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e.,worse outcome).
  • Change From Baseline to Month 12 in PROMIS-29 - Pain Interference [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain interference domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
  • Change From Baseline to Month 12 in PROMIS-29 - Ability to Participate in Social Roles & Activities [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the ability to participate in social roles and activities domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).
  • Change From Baseline to Month 12 in PROMIS-29 - Pain Intensity [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain intensity domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
  • Change From Baseline to Month 12 in SCTC GIT - Composite Score [ Time Frame: Baseline and Week 52 ]
    The SCTC GIT is the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Instrument. It assesses scleroderma-related gastrointestinal symptoms. The composite score ranges from 0 to 2.83; 0 indicates better health and higher score indicates worse health.
  • ACR CRISS at 12 Months [ Time Frame: Week 52 ]
    The American College of Rheumatology Combined Response Index in Systemic Sclerosis is a composite endpoint. It is determined in a 2-step process. The first step assesses whether the patient has had a significant decline in renal or cardiopulmonary involvement. If none of these apply, the second step assesses the probability of improvement by measuring changes in five outcomes and integrating them into a single number using an equation described in Khanna D, Berrocal VJ, et al. [The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis. Arthritis and Rheumatology. 2016; 68(2):299-311.]. It incorporates changes in the modified Rodnan skin score, percent predicted forced vital capacity (FVC), patient and physician global assessments, and SHAQ-DI over 1 year. The score ranges from 0 to 1; a higher score indicates better outcome.
  • Change From Baseline to Month 12 in PROMIS - Fatigue [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 8-question short-form health-reported quality of life measure fatigue domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
  • Change From Baseline to Month 12 in PROMIS - Sleep Disturbance [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 4-question short-form health-reported quality of life measure sleep disturbance domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).
  • Change From Baseline to Month 12 in PROMIS - Sleep Impairment [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 8-question short-form health-reported quality of life measure sleep impairment domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
  • Change From Baseline to Month 12 in HAQ-DI - Dressing and Grooming [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
  • Change From Baseline to Month 12 in HAQ-DI - Hygiene [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
  • Change From Baseline to Month 12 in HAQ-DI - Arising [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
  • Change From Baseline to Month 12 in HAQ-DI - Reach [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
  • Change From Baseline to Month 12 in HAQ-DI - Eating [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
  • Change From Baseline to Month 12 in HAQ-DI - Grip [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
  • Change From Baseline to Month 12 in HAQ-DI - Walking [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
  • Change From Baseline to Month 12 in HAQ-DI - Common Daily Activities [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2014)
  • Positive or negative change on 28- tender/swollen joint counts [ Time Frame: Baseline and 52 weeks ]
  • Change in subject reported outcomes [ Time Frame: Baseline and 52 weeks ]
    Quality of life questionaires will be used to capture this data.
  • Change in % predicted FVC [ Time Frame: Baseline and 52 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: June 9, 2014)
  • Development of new/worsening cardiac involvement [ Time Frame: Between baseline and 1 year ]
  • Change in blood and skin biomarkers [ Time Frame: Between baseline and 6 months ]
  • Digital ulcer net burden at 12 months [ Time Frame: 1 year ]
  • New Renal Crisis [ Time Frame: 1 year ]
  • Change from baseline in BMI [ Time Frame: 1 year ]
 
Descriptive Information
Brief Title  ICMJE A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis
Official Title  ICMJE A Phase 2 Study to Evaluate Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis- a Double-blind, Placebo-controlled, Randomized Controlled Trial.
Brief Summary The study hypothesis is that SC abatacept is safe and shows evidence of efficacy (improvement in modified Rodnan score [mRSS]) in patients with diffuse cutaneous systemic sclerosis (dcScc) compared to matching placebo.
Detailed Description This study is a randomized placebo-controlled double-blind phase 2 trial of patients with dcSSc. Eligible participants will be randomized in a 1:1 ratio to either 125 mg SC abatacept or matching placebo, stratified by duration of dcSSc disease duration (<18 months vs >18 to </=36 months). Study participants will be treated for 12 months on double-blind study medication, followed by an additional 24 weeks of open-label SC abatacept therapy. 86 patients will be randomized in approximately 35 centers in the US, Canada and Europe, with the goal of analyzing 74 participants. The investigators study will test whether abatacept is statistically superior to placebo in reducing the MRSS at month 12 and explore the ability of abatacept to prevent or reverse progression in patients with early disease duration and lower MRSS scores, and reverse established disease in patients with longer disease duration and higher MRSS scores.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Cutaneous Systemic Sclerosis
Intervention  ICMJE
  • Drug: Abatacept
    Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks
    Other Name: Orencia
  • Drug: Placebo
    125 mg of Placebo
Study Arms  ICMJE
  • Active Comparator: Abatacept
    125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension
    Intervention: Drug: Abatacept
  • Placebo Comparator: Placebo
    125mg Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2018)
88
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2014)
86
Actual Study Completion Date  ICMJE October 17, 2018
Actual Primary Completion Date September 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosis of Systematic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc
  2. Diffuse Systemic Sclerosis (dcSSc) as defined by LeRoy and Medsger
  3. Disease duration of ≤ 36 months (defined as time from the first non−Raynaud phenomenon manifestation)
  4. For disease duration of ≤ 18 months: ≥ 10 and ≤ 35 mRSS units at the screening visit
  5. For disease duration of >18-36 months: ≥ 15 and ≤ 45 mRSS units at the screening visit and one of the following:

    • Increase ≥ 3 in mRSS units compared with the last visit within previous 1-6 months
    • Involvement of one new body area with ≥ 2 mRSS units compared with the last visit within the previous 1-6 months
    • Involvement of two new body areas with ≥ 1 mRSS units compared with the last visit within the previous 1-6 months
    • Presence of 1 or more Tendon Friction Rub
  6. Age ≥ 18 years at the screening visit
  7. If female of childbearing potential, the patient must have a negative pregnancy test at screening and baseline visits
  8. Oral corticosteroids (≤ 10 mg/day of prednisone or equivalent) and NSAIDs are permitted if the patient is on a stable dose regimen for

    • 2 weeks prior to and including the baseline visit.
  9. ACE inhibitors, calcium-channel blockers, proton-pump inhibitors, and/or oral vasodilators are permitted if the patient is on a stable dose for ≥ 2 weeks prior to and including the baseline visit.

Exclusion Criteria:

  1. Rheumatic disease other than dcSSc; it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy
  2. Limited cutaneous systemic sclerosis or sine scleroderma at the screening visit
  3. Major surgery (including joint surgery) within 8 weeks prior to screening visit
  4. Infected ulcer prior to randomization
  5. Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit
  6. Previous treatment with cell-depleting therapies, including investigational agents, including but not limited to, CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, and ABA
  7. Anti-CD20, and cyclophosphamide within 12 months prior to baseline visit.
  8. Use of Intravenous Immunoglobulin (IVIG) within 12 weeks prior to baseline visit
  9. Previous treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation
  10. Immunization with a live/attenuated vaccine within ≤ 4 weeks prior to the baseline visit
  11. Treatment with methotrexate, hydroxychloroquine, cyclosporine A, azathioprine, mycophenolate mofetil rapamycin, colchicine, or D-penicillamine, within≤ 4 weeks prior to the baseline visit
  12. Treatment with etanercept within ≤ 2 weeks, infliximab, certolizumab, golimumab, ABA or adalimumab within ≤ 8 weeks, anakinra within ≤ 1 week prior to the baseline visit
  13. Pulmonary disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin ) ≤ 40% of predicted at the screening visit
  14. Pulmonary arterial hypertension (PAH) as determined by right heart catheterization or on PAH approved medications for PAH. It is acceptable to use PDFE-5 inhibitors for Raynaud's and digital ulcers.
  15. Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be participants with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).
  16. Positive for hepatitis B surface antigen prior to the baseline visit
  17. Positive for hepatitis C antigen, if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay prior to baseline visit
  18. Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be participants with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).
  19. Any of the following at the screening visit: Hemoglobin <8.5 g/dL; WBC < 3,000/mm3 (<3 x 109/L); platelets < 100,000/mm3 (<3 x 109/L); serum creatinine > 2 x ULN; serum ALT or AST > 2 x ULN
  20. Severe skin thickening (mRSS 3) on the inner aspects of thighs, upper arms, or abdomen
  21. Patients with a history of anaphylaxis to abatacept
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02161406
Other Study ID Numbers  ICMJE IM101-344
1UM1AI110557 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dinesh Khanna, MD, MS, University of Michigan
Study Sponsor  ICMJE Dinesh Khanna, MD, MS
Collaborators  ICMJE
  • Bristol-Myers Squibb
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Principal Investigator: Dinesh Khanna, MD, MS University of Michigan
PRS Account University of Michigan
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP